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Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator. ISO 11137-1:2006 does not:
|
| 국제분류(ICS)코드 | 11.080.01 : 일반 살균 및 소독 |
| 페이지수 | 37 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 11137-1:2006/Amd 2:2018 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4 and 11.2 | 2018-11-08 | 표준 |
| 2 | ISO 11137-1:2006/Amd 1:2013 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1 | 2013-07-16 | 표준 |
| 3 | ISO 11137-1:2006 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | 2006-04-19 | 표준 |
ISO/FDIS 11137-1 - Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices 상세보기
ISO 11137-2:2013 - Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose 상세보기
ISO 11137-1:2006/Amd 1:2013 - Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1 상세보기
CSA ISO 11137-2:16 (R2021) - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (Adopted ISO 11137-2:2013, third edition, 2013-06-01) 상세보기
CAN/CSA-ISO 11137-3:17 (R2022) - Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control (Adopted ISO 11137-3:2017, second edition, 2017-06) 상세보기
ISO 11137-1:2006/Amd 2:2018 - Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4 and 11.2 상세보기
ISO 11137-1:2006/Amd 1:2013 - Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1 상세보기
ISO 11137-2:2013 - Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose 상세보기
ISO 11137-3:2017 - Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control 상세보기
ISO 11135:2014 - Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
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